MAUDE Adverse Event Report: ARTHREX, INC. K-LESS T-ROPE W/DRV, SYN REPR, TI; WASHER, BOLT, NUT

Model Number	K-LESS T-ROPE W/DRV, SYN REPR, TI
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a syndesmosis ruptur surgery the medial button flipped too early at the space in between.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.The complaint allegation was confirmed.One unpackaged ar-8925t serial/batch (b)(6) was received for evaluation.Functional testing was not performed as the suture arrived broken for evaluation.The visual evaluation revealed that the sutures and the suture system holding both buttons together were broken and frayed.The tip of the inserter shaft was also bent.The most probable cause of the reported failure is user error, which may have resulted from excessive force applied during insertion and/or misalignment of the device.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 one unpackaged ar-8925t serial/batch (b)(6) was received for evaluation.Functional testing was not performed due to damage to both the suture system and the inserter.Visual evaluation revealed that the suture system connecting the two buttons was broken and frayed.Additionally, the suture strands showed signs of damage, including frayed filaments.The inserter's evaluation found that the tip was broken off; the remaining tip piece showed a bend.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause of the reported failure is user error.This includes inadequate bone tunnel preparation, which can lead to uneven passage; improper tensioning of the suture during deployment; incorrect alignment of the inserter prior to insertion; and premature pulling of the suture before the button is fully positioned.Directions for use dfu-0147-eor3_fmt_en.Tightrope® devices g.Precautions 1.Acl/pcl/btb/rt/abs tightrope only: excessive force on the shortening suture strands and/or tensioning the shortening suture strands not in-line with the bone socket may break the strands and impair ability to fully seat the implant.No additional force on the shortening suture strands is required when the graft/wedge construct reaches the desired position in the femoral socket and the graft stability is verified by pulling distally on the graft.3.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or contact your arthrex representative for an onsite demonstration.

• Brand Name: K-LESS T-ROPE W/DRV, SYN REPR, TI
• Common Device Name: WASHER, BOLT, NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21972927
• Report Number: 1220246-2025-01930
• Device Sequence Number: 20639811
• Product Code: HTN
• UDI-Device Identifier: 00888867281608
• UDI-Public: (01)00888867281608(11)240930(17)290831(10)15324134
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K043248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: K-LESS T-ROPE W/DRV, SYN REPR, TI
• Device Catalogue Number: AR-8925T
• Device Lot Number: 15324134
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 09/02/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 08/25/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown